Lymfit Exercise Program for Lymphoma Survivors (Lymfit_RCT Trial)

N/A

Recruiting

Research Sponsored by McGill University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an exercise program using mobile technology can improve fitness and quality of life for lymphoma survivors.

Who is the study for?

This trial is for lymphoma survivors aged 18-39, who've had chemotherapy with curative intent in the last 6 months. Participants need approval from their hematologist to do vigorous exercise, must own a smartphone compatible with Fitbit, be able to complete online questionnaires, and have home internet for video coaching sessions.

What is being tested?

The study is testing if a mobile-health supported exercise program called Lymfit can boost fitness and life quality in lymphoma survivors. It's a randomized control trial where some will enter the program immediately while others will be on a waitlist.

What are the potential side effects?

Since this intervention involves an exercise program, potential side effects may include typical workout-related issues such as muscle soreness or strain. However, participants are pre-screened for any health conditions that could make vigorous exercise unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of the exercise guideline as determined by comparing the active minutes captured in the Fitbit

Secondary study objectives

Change from baseline Fear of Cancer Recurrence assessed by the Cancer Worry Scale (CWS)

Change from baseline Work Ability assessed by the Work Ability Index (WAI)

Change from baseline multi-dimensional Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System-29

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist controlExperimental Treatment1 Intervention

Participants will receive the exact same Lymfit exercise intervention 3 months after they consent to participate in the study.

Group II: Lymfit exercise interventionExperimental Treatment1 Intervention

Participants randomized to the intervention group will be allocated a pre-registered Fitbit, a personalized exercise prescription designed by the kinesiologist, and 12 weeks of supervision by the kinesiologist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Waitlist control

2007

Completed Phase 2

~4170

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